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Daridorexant / Quviviq, a new class of sleeping pills: Prescrire’s opinion

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At the beginning of 2023, the evaluation of daridorexant (Quviviq), a sleeping pill of a new class, “is too incomplete to test this drug on patients outside of clinical trials», Estimates the magazine Prescrire in its May 2023 issue.

It had been several years since any sleeping pill from a new pharmacological group had been authorized in the European Union.»

In this context, the marketing authorization (AMM) of daridorexant (Quviviq), an orexin A and B receptor antagonist, could raise hope“, comments the review.

This class of sleeping pill works by inhibiting the mechanisms that maintain wakefulness rather than the mechanisms that induce sleep like other sleeping pills do.

In fact, the clinical evaluation of daridorexant was not designed to demonstrate any progress compared to another sleeping pill. Two randomized, double-blind trials compared it with a placebo, in a total of 1,854 patients bothered by chronic insomnia, most often moderate and without associated mental disorders.»

Compared to a placebo, daridorexant appears to accelerate falling asleep by a few minutes and lengthen the perceived duration of sleep by 10 to 20 minutes.»

He “exposes to headaches, drowsiness, fatigue and dizziness. Some data suggest misuse, as well as insomnia rebounds and withdrawal syndromes when the drug is stopped. Some side effects need to be better defined, in particular sleep paralysis and depression.»

When a drug is considered, it seems more prudent to stick to sleeping pills already available, despite their limitations, supported by their long experience of use.concludes Prescrire.

After a few decades of use against insomnia, we know that benzodiazepines (e.g. Xanax, Lexomil…) and related substanceshave at best modest effectiveness, often limited in time, and sometimes serious adverse effects“recalls the review. (List of benzodiazepines marketed in France)

Another sleeping pill belonging to this new class of orexin receptor antagonists is suvorexant (Belsomra), notably authorized in 2014 in the United States.

For more information on insomnia, see the links below.

Psychomedia with source: Prescribe.
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